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IUI Catheter
EUDAMEDFDA UDIClass I (EU MDR)
Ref 131184Ref 131104Ref 140198Ref 131102Ref 131186Ref 131182
Identity
- Trade Name
- kitazato IUI Catheter FDA UDI
- Generic Name
- Assisted reproduction transfer catheter/set FDA UDI
- Device Name
- IUI Catheter EUDAMEDStylet for 180mm Catheter, model number Type6-v1 FDA UDI
- Model / Reference
- 131184 EUDAMED131104 EUDAMED140198 EUDAMED131102 EUDAMED131186 EUDAMED131182 EUDAMED140118 Type6-v1 FDA UDI
- Description
- Stylet for 180mm Catheter, model number Type6-v1 FDA UDI
Identifiers
- Catalog Number
- 140118 FDA UDI
- Primary DI / UDI-DI
- 04580303266670 EUDAMED04580303266878 EUDAMED04580303266687 EUDAMED04580303266861 EUDAMED04580303267288 EUDAMED04580303266663 EUDAMED04580303269275 FDA UDI
- Basic UDI-DI
- 458223146IUIJZ EUDAMED
- 510(k) Number
- K162667 FDA UDI
- FDA Product Code
- MQF FDA UDI
- EMDN Code
- U08020101 CATHETERS FOR INSEMINATION EUDAMED
- GMDN Term
- Assisted reproduction transfer catheter/set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6110 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
IUI Catheter by Kitazato Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458223146IUIJZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kitazato Corporation
- EUDAMED SRN
- JP-MF-000018374
- Authorised Representative
- BIOMEDICAL SUPPLY, S.L. ES-AR-000014358
Sources (7)
- EUDAMED be0140d2-25ca-4b16-a55c-40b84e62de35 61 fields · synced Jul 25, 2026
- EUDAMED 5c705c9b-f784-4531-854e-65cd1666ffd7 61 fields · synced May 17, 2026
- EUDAMED 483c0cbc-eae5-4bab-af53-5c451c2602b3 61 fields · synced May 17, 2026
- EUDAMED 7e37c88f-e2ac-40fd-87a0-eedbb46d047a 61 fields · synced May 17, 2026
- EUDAMED ef0628c5-0da6-48ca-a528-03c5a9f90f4d 61 fields · synced May 18, 2026
- FDA UDI cd549ee6-bee3-41ed-8d6b-cef0bf414c5b 35 fields · synced May 29, 2026
- EUDAMED a8af5809-5def-4e8a-9a08-588b9e9eb549 61 fields · synced Jul 17, 2026